Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Information source: Nantes University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrence of Urinary Tract Infection
Intervention: Antimicrobial prophylaxis (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s):
Claude GUYOT, MD, Principal Investigator, Affiliation: Nantes University Hospital
Summary
Randomised, prospective, multicentric study in order to assess the usefulness of
antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or
less).
Clinical Details
Official title: Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Primary outcome: End point : recurrence of urinary tract infection during the study period (0 รจ 18 months)
Secondary outcome: 1) Type of urinary tract infection (pyelonephritis or cystitis)2) Evaluation of the quality of life with a validated questionnaire done at 9 months
Detailed description:
A voidingcystourethrogram was performed for each child less than 3 year old with a first
urinary tract infection. In case of vesico-ureteral reflux, a randomisation was done between
continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no
antibioprophylaxis. Duration of follow up was 18 months
Eligibility
Minimum age: N/A.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children less than 3 year old
- First proved urinary tract infectionIsolated vesico-ureteral reflux
- Parents have been fully informed and have given written informed consent to
participate in the study
Exclusion Criteria:
-
Locations and Contacts
Nantes University Hospital, Nantes, France
Additional Information
Starting date: April 2001
Last updated: September 12, 2005
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